PRECEPT MEDICAL PRODUCTS, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mask, Surgical (FXX) (7) Accessory, Surgical Apparel (LYU) (2) Respirator,Surgical (MSH) (1)

Premarket Exempt

No Yes

Clear

Precept® - 10814707020592 Catalog Number :

Device Description : N95 SURGICAL RESPIRATOR - SMALL

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : MSH

Prescription Use : No

Device Count : 20

Precept® - 10814707020608 Catalog Number :

Device Description : ISOLATION MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 50

Precept® - 10814707020615 Catalog Number :

Device Description : ISOLATION MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 50

Precept® - 10814707020622 Catalog Number :

Device Description : Procedure Mask

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 500

Precept® - 10814707020646 Catalog Number :

Device Description : FLUID RESISTANT PROCEDURE MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020653 Catalog Number :

Device Description : FLUID RESISTANT ANTI-FOG PROCEDURE MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020660 Catalog Number :

Device Description : FLUID RESISTANT PROCEDURE MASK WITH EXTENDED SHIELD

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020677 Catalog Number :

Device Description : FLUID RESISTANT SURGICAL MASK

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Precept® - 10814707020684 Catalog Number :

Device Description : FLUID RESISTANT SURGICAL MASK WITH EXTENDED SHIELD

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Precept® - 10814707020691 Catalog Number :

Device Description : FLUIDGARD® 120 ANTI-FOG SURGICAL MASK WITH EXTENDED SHIELD

Device Class :

Duns Number: 783912892

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

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